Carotid Artery Implant for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants (CAPTURE2)

Carotid Artery ImPlant for Trapping UpstReam Emboli (CAPTURE 2) for Preventing Stroke in Atrial Fibrillation Patients Taking Oral Anticoagulants

This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: Vine™ Embolic Protection System

Detailed Description

The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for ~20% of the entire AF population, which is ~300K/year in the United State and EU. The implant is designed to exclude emboli > 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is > 1.5 mm

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis
  • Antwerp, Belgium
    • ZNA Stuivenberg
• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• Germany
  • Essen, Germany, 45131
    • Alfried-Krupp Krankenhaus Rüttenscheid
  • Frankfurt, Germany
    • Cardioangiologisches Centrum Bethanien
  • Frankfurt, Germany, 60389
    • Cardio Vasculäres Centrum Frankfurt
• Greece
  • Athen, Greece
    • Laiko Hospital
  • Athens, Greece, 11527
    • General Hospital of Athens "Hippokrateio"
  • Larissa, Greece
    • University General Hospital of Larisa
  • Thessaloníki, Greece, 57001
    • European Interbalkan Medical Center
• Hungary
  • Budapest, Hungary
    • Gottsegen Gyorgy Hungarian Institute of Cardiology
• Israel
  • Haifa, Israel
    • Carmel
  • Jerusalem, Israel, 9103102
    • Shaari Tzedek
  • Petah tikva, Israel
    • Rabin Medical Center (RMC)
  • Tiberias, Israel, 1520800
    • Poria
• Poland
  • Poznań, Poland
    • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Pracownia Hemodynamiki Serca
• Spain
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented AF
• CHA2DS2-VASc score ≥ 4 and history of ischemic stroke (including TIA with positive neuro-imaging)
• No contra-indication for patient to receive an OAC, either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC) for the duration of the study
• Age > 50 years
• Maximal (systolic) CCA diameter range: ≥ 4.8mm and ≤ 9.8mm
• CCA accessibility: up to 40mm from skin to CCA center, safe approach
• Implantation segment free of atherosclerotic disease as determined by ultrasound imaging
• Patient is able and willing to provide informed consent

Exclusion Criteria:

• Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)]
• Evidence of carotid dissection
• Pre-existing stent(s) in CCA
• Female who is pregnant or who is planning to become pregnant during the course of the study
• Life expectancy of less than two years
• Active systemic infection
• Known sensitivity to nickel or titanium metals, or their alloys
• Known hereditary or acquired coagulation disorders
• Any planned surgical or endovascular treatment within 30 days after the implantation procedure
• A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments* Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day)
• Active participation in another investigational drug or device treatment study
• Inability to complete all scheduled follow-up
• Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the study
• History of intracerebral hemorrhage (ICH) and/or hemorrhagic stroke
• Event of stroke/TIA in the past 14 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vine™ Filter + OAC; Vine™ Filter in each common carotid artery (CCA) with oral anticoagulant treatment (either vitamin K antagonist (VKA) or novel oral anticoagulant (NOAC)) for the duration of the study

Device: Vine™ Embolic Protection System; The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications	Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following: Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries; Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation; Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability	30 days from implantation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.	Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries; Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation; Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability	one and two years from implantation procedure
Number of properly positioned implants	proper implant position in each common carotid artery (CCA)	30 days from implantation procedure
Number of participants that had disabling strokes	Disabling stroke	30 days, one and two years from implantation procedure
Number of Implantation success	implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability	immediately after the procedure
Number of properly positioned implants	Proper implant position in each CCA	one and two years from implantation procedure
Number of observed thrombi on the device	Thrombus on implant detected by ultrasound imaging	30 days, one and two years from implantation procedure
Number of death cases	Death	one and two years from implantation procedure
Number of strokes (any kind)	Total number of strokes	one and two years from implantation procedure

Collaborators and Investigators

• Sponsor: Javelin Medical
• Collaborators: Genae

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): October 24, 2024
• Study Completion (Estimated): October 24, 2027

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Carotid; Filter; AF; Emboli; OAC
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: CL-326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No